Film Coating

Film coating is a process, which involves the

deposition of a membrane (usually 20-100μm thick)
consisting of polymer, plasticizer, colorant and
possibly other additives on to the surface of a
pharmaceutical dosage form, typically a tablet or a
granule.
 Theory of Film Coating

Tablet film coating is based on two distinct phenomena-

First: Formation of film over the core tablet (cohesion)

and
Second: Bonding between the polymeric film and the
core tablet surface (adhesion).

Cohesion is also known as autohesion or self-adhesion

refers to the ability of contiguous surfaces of the same
material, at a molecular or at a supermolecular level, to
form a strong bond, which prevents or resists
separation at the point of contact.
 Theory of Film Coating

To obtain high levels of cohesion, two phenomena

are necessary-

• The cohesive (autoadhesive) strength of the

material, molecule to molecule must be relatively
high and
• The contiguous surfaces of the film material must
on contact.
 Theory of Film Coating

Coalescence or disappearance of boundary layers

between adjacent polymer molecular layers or surfaces
is explained by diffusion theory. According to this
theory, movement (diffusion) of individual
macromolecules or segments of macromolecules
between and within film layers may occur under a
variety of conditions including during-

• gelation
• when polymers are deposited in solution over a
previous polymer layer.
• At elevated temperatures corresponding to a semi-
solid state.
 Important Features of Film Coating

Mechanical Properties:

• Visual quality of coating.

• Protection from environmental hazards
(moisture, light, heat).
• Resistance to damage on handling.
• Drug release characteristics from modified
release products.
• Taste masking efficiency.
 Important Features of Film Coating
Permeability Characteristics:

• Barrier properties of coating.

• Product stability.
• Drug release characteristics from modified products.
• Taste masking efficiency.

Coating solution viscosity:

• Spraying characteristics.
• Interaction with substrate.
• Visual quality of coating. (Spraying through the orifice should
be properly done. So optimum viscosity should be maintained)
 Important Features of Film Coating

Hiding Power:

• Visual quality.
• Quantity of coating needed for uniform appearance.
• Stability of photolabile actives. (Ranitidine is a light-
sensitive drug. So it should be coated)
 Reasons for Film Coating
• Protection of the drug from its surrounding environment
(particularly air, moisture and light) with a view to improving
stability.

• Masking of unpleasant taste and odor.

• Increasing the ease by means of which, the product can be

ingested by the patient.

• Improving product identity from the manufacturing plant through

intermediates and to patient. It also decreases the risk of
confusion especially when patients have to take several
preparations.

• Facilitating handling particularly in high speed packaging or filling

lines and automated counters in pharmacies where the coating
minimizes cross-contamination due to dust elimination.
 Reasons for Film Coating
• Improvement in product appearance particularly where
there are noticeable visible differences in tablet core
ingredients from batch to batch.
• Reducing the risk of interaction between incompatible
components. This would be achieved by using coated forms of
one or more of the offending ingredients (particularly active
compounds).
• Improvement in product mechanical integrity since coated
products are generally more resistant to mishandling (abrasion
attrition etc).
• Modification of drug release as in enteric coated, repeated action,
rapid action, and sustained release, controlled release products.

• Improves the aesthetic value.

• A simplified process that facilitates automation.

 Advantages of Film Coating

• The coating adds only 10-20mg to tablet weight.

• The coating can be applied from an anhydrous solvent so

that tablet sealing is unnecessary.

• The process readily loads itself to automation and is rapid.

• The coating is noncaloric and virtually flavorless and is less

likely to be mistaken for candy by children.

• The identity of embossed tablets may be maintained or the

films may readily be imprinted for product identity.
 Advantages of Film Coating

• Technician training is easier.

• It can be prepared with little or no increase in

disintegration time or rate of dissolution and
release compared with uncoated tablets.

• As it is an organic solution, it is stable and is not

growth media for microorganism.

• It optimizes the shelf-life of a tablet.

 Ingredients Used in Film Coating

Formulation contains-

Polymer
Plasticizer
Colorant
Solvent
 Polymers Used in Film Coating

The polymer should have good solubility in

aqueous fluid, a low viscosity. Effect of polymer
molecular weight on coating properties-

Tensile strength:
It improves, when the polymer molecular weight is increased. But it
decreases, when the plasticizer amount is increased.

Elastic modulus:
When the polymer molecular weight is increased, the elastic modulus
is decreased. Physical bonding is effective in low molecular weight
polymer. But the elastic modulus decreases, when the plasticizer
amount is decreased.
 Polymers Used in Film Coating
Film adhesion:
This is typically unaffected by the molecular weight unless the structural properties
are related.

Solution viscosity:
If the mol. weight of a substance is high, it will significantly increase the viscosity.
Generally HPMC 3cps is used, but when HPMC 170cps is used, it will contain high
mol. weight polymer. The ↑the mol. Weight, the ↑ will be the consistency.
PEG › 4000 = solid PEG › 1000 = semi-solid PEG (100-400), liquid

Film permeability:
The film permeability will increase with the increase in mol. Weight.

Tg:
It is the temperature below which, a substance behaves like a glass. When the mol.
Weight increases, the Tg of a substance is reduced.
 Polymer used in conventional film coating
formulations
Class Examples

Cellulosic Hydroxy Propyl Methyl Cellulose (HPMC)

Hydroxy Propyl Cellulose, Hydroxy Ethyl Cellulose
Methyl Hydroxy Ethyl Cellulose
Methyl Cellulose, Ethyl Cellulose
Sodium Carboxy Methyl Cellulose
Vinyls Polyvinyl Pyrrolidone

Glycols Polyvinyl Ethylene glycols,

Acrylics Dimethyl amino ethyl methacrylate-methyl-acrylate acid
ester co-polymer
Ethyl acrylate-methyl methacrylate copolymer.
Eudragit RL, Eudragit RS, Eudragit RL-PO
 Cellulosic System

HPMC is the most widely used polymer in film coating.

The hydroxy propyl substitution gives the polymer superior organic

compatibility.

Good organic compatibility while maintaining good water solubility is

also a feature of hydroxy propyl cellulose.

It is probably due to the formation of side chains during its manufacture.

 Cellulosic System
Properties-

a) They are all white or off-white odorless and tasteless

powder.
b) They are soluble in cold water and insoluble in hot water.
c) Low viscosity grade is used in aqueous film coating so that
high solid content can be incorporated into coating system.
d) HPMC gives clear, tough, flexible films from aqueous and
organic media.
e) It takes printing easily and can be used to coat tablets with
logos and sharp edges.
f) It tends to be sticky during processing.
g) It is the subject of monograph.
 Cellulosic System
Advantages of cellulosic system:

1. System is comparatively simple. A typical formulation for

spraying would contain polymer, pigment or opacifier,
plasticizer and water that can be modified depending upon
the individual needs.
2. If required, film strength can be improved by using high
mol. weight HPMC and reducing the solid content.
3. Elegant product can be produced by using 2:1 of polymer
and pigment. High pigment concentration produces tastes
coverage but rough and discontinuous film.
4. Plasticizers, of water based can be used, which was before
used as organic solvent base.
 Plasticizers

Plasticizers may be defined as non-volatile, low molecular

weight substance added to higher polymers to soften and
render them plastic or flexible during processing or to impart
permanent flexibility and rubber like extensibility.

Plasticizers reduce the Tg of amorphous polymer

Plasticizers are used to impart flexibility to the polymer.

They make it more usable and decrease the brittleness.

 Glass Transition Temperature (Tg)
Glass transition temperature (Tg) may be defined as the
temperature below which there is a critical cessation of
molecular motion on the local scale.

Under this temperature condition, the polymer exhibits many

of the properties of inorganic glasses including toughness,
hardness, stiffness and brittleness.

For this reason, the glass transition temperature is often

described as one, below which a polymer is brittle and above
which, is flexible.
 Classification of Plasticizers
Depending on solubility, plasticizers can be classified into two classes-

Water-soluble:
a) Propylene glycol
b) Glycerin
c) Polyethylene glycol and
d) Polysorbates

Water-insoluble:
Triacetin
a) Acetylated monoglycerides
b) Pthalate ester
c) Castor oil
d) Span
 Common plasticizers used in conventional
film coating

Class Example
Polyhydric alcohols Propylene glycol
Glycerol
Polyethylene glycol

Acetate esters Glycerol triacetate

Triethyl citrate
Acetyl triethyl citrate

Pthalate esters Diethyl pthalates

Glycerides Acetylated monoglycerides
Oils Castor oil
Mineral oil
 Colorants

Colorants usually enhance the aesthetic appeal and

obviously aid in product identification and also enhance the
physical properties of applied film coats.

Colorants mask the appearance of the substrate and thus

facilitate the uniformity of colored appearance.

They are
Synthetic organic dyes and their lakes
Inorganic pigments
Miscellaneous natural colorants
 Colorants
Synthetic organic dyes and their lakes:

Sunset yellow, Tartrazine, Amaranth, Erythrosine, Brilliant blue, as

water-soluble, their use is extremely restricted regarding the coloring of
any form of coated tablet.
However, their water-insoluble complexes with hydrated alumina,
known as lakes, are in widespread use as colors for coated tablets.

Laking Process:
Hydrated alumina is produced by reacting aluminum chloride with
sodium carbonate. The appropriate dye in aqueous solution is then
adsorbed on to the prepared alumina hydrate. Finally additional
aluminum chloride is added to ensure complete formation of the
aluminum salt of the dye. Then filtration is done. Finally wash the
filtrated dye and dry to get the lake colors.
 Colorants
Inorganic pigments:
These have stability towards light. They have a wide regulatory
acceptance. Range of colors that can be achieved, is rather limited.
Example-
a. Iron oxides (FeO)
b. Titanium di-oxide (TiO2)
c. Calcium carbonate (CaCO3)
d. Talc

Miscellaneous natural colorants:

This group includes all the colors extracted from naturally occurring
materials of vegetable and animal origin.
Example-Anthocyanins, Carotenoids, Chlorophyll, Riboflavin, Carmine,
Indigo, Flavones, Turmeric
 Problems in film coating
The problems, which are all common to conventional film coating and
the aqueous process, are discussed here-

Picking:
It is described as a situation in which the coating of two adjacent tablets
is not sufficiently dry before contact and they stick together. To make
them apart, they are broken only. These film fragments glued on to the
unaffected surface. It happens when insufficient drying conditions exist
and when excessive coating solution is applied. A reduction in liquid
application rate, an increase in drying tem and air volume usually solve
this.

Peeling:
It is extensive condition of picking, characterized by larger film
fragments flaking from the tablet surface. It happens when the tablet bed
is over wetted.
 Problems in film coating
Bridging:
It is characterized by partial or complete detachment of the coating (from
the substrate) in the region of the logo. It is the manifestation of the
polymer-related adhesion problem in which the internal stress of the film
is relieved by the formation of a polymer bridge. Increase the plasticizer
content or change the plasticizer solve this.

Orange peel:
It is characterized by roughness of the tablet arising from the failure of
the spray droplets to coalesce. The droplets of the coating liquid must dry
very soon after they make contact with the tablet surface. It is caused by
drying of the polymer spray before it hits the surface. It is so called due
to the resemblance to the skin of an orange. Thinning of the solution with
additional solvent corrects this.
 Problems in film coating
Mottling:
It describes an uneven distribution of color on the tablet surface. It is
mainly caused by inadequate pigment dispersion in the film or by the
migration of soluble dyes. The use of lake dyes eliminates this problem.
A reformulation with different plasticizers and additives is the best way
to solve this.

Cracking:
It is a manifestation of internal stress in the coating. In these instances,
the stresses in the coating exceed the tensile strength of the coating
material, which cracks to relieve the stress. Adjusting the type and
concentration of the plasticizer and the pigment, solves this.
 Problems in film coating

Two unique problems may occur with the aqueous processes are-

Erosion:
Erosion of the tablet surfaces arises when tablet cores are soft and the
processing times are long causing an increase in attribution.

Over-wetting:
Over-wetting of the tablet is characterized by adhesion of the tablet
materials to the sides of the coating pan and to each other. Over wetting
and moisture penetration can also lead to drug stability problems later.
 Difference between sugar coating and film coating
Features Sugar coating Film coating
Tablet: Rounded with high degree of Retain contour of original core
Appearance polish usually not as shiny as sugar
coat types.
Weight increase due to coating 30-50% 2-3%
materials
Logo or break lines Not possible Possible
Other solid dosage forms Coating is possible but little Coating of multiparticulates
industrial importance very important in modified
release forms
Process: Considerable Process lends itself to
Operator training required automation and easy training of
operators.
Adaptability to GMP Difficulties can arise High
requirements
Process stages Multiple process Usually single stage
Functional coatings Not usually possible apart from Easy adaptable for controlled
enteric coating release
Typical batch coating time 8 hrs or more 1.5-2 hrs
Ingredients used Polymer, colors, solvents Polymers, plasticizers, colors,
solvent